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Stanford University
Stanford, CA, United States
Source: Stanford University careers · View original posting
From Stanford University's posting. “We” and “our” refer to the employer.
Responsible for ensuring the institution's compliance with policies and procedures regarding the use of human subjects, laboratory animals, or stem cells in accordance with Stanford's HRPP (Human Research Protection Program) and mandated federal laws and regulations.
IRB Coordination Manager (Research Compliance Manager 1)
This position is a hybrid work role
– a combination of onsite work and telecommuting – based on business and operational need.
$99,448 - $140,000
The Human and Animal Research Compliance (HARC) office is responsible for oversight and management of Stanford’s Administrative (Compliance) Panels and ensures compliance with applicable policies, accreditation standards and external regulations. Our goal at HARC is to help facilitate research and to make sure it is done safely, ethically, and legally. We take pride in being service-oriented.
Stanford University's IRB is charged with ensuring that all aspects of Stanford’s Human Research Protection Program comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position, which is core to Stanford’s research compliance activities, focuses primarily with medical Research.
We are seeking a candidate experienced with regulatory compliance and institutional review boards (IRBs) and that has excellent customer service skills.
In this position, under the direction of the HRPP Manager and the IRB Chair, you will conduct in-depth protocol review using advanced regulatory knowledge and experience. The primary responsibility will be to manage the protocol review process for Continuing Reviews (renewals) and Modifications to identify issues, and independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, Stanford University policies, and accreditation standards.
You will also be involved in:
Developing, implementing, and managing efficient procedures to facilitate the processing of human protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
Performing review of complex research protocols, including identifying problems and issues in the submission application and contacting the investigator orally or in writing to request additional materials.
Planning and coordinating IRB review and follow-up activities.
Serving as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
Applying knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance.
Providing assistance to management in preparation for accreditation and in various compliance and quality assurance activities.
*Please note this position may require the following:
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